Anafranil Coated Tablets 25mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CLOMIPRAMINE HYDROCHLORIDE

Available from:

Novartis Ireland Limited

ATC code:

N06AA04

INN (International Name):

CLOMIPRAMINE HYDROCHLORIDE

Pharmaceutical form:

COATED TABLET

Composition:

CLOMIPRAMINE HYDROCHLORIDE 25 milligram(s)

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Authorised

Authorization date:

2005-11-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ANAFRANIL 10MG AND 25MG COATED TABLETS
ANAFRANIL 75MG SUSTAINED-RELEASE TABLETS
CLOMIPRAMINE HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours

If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET
1
What Anafranil is and what it is used for
2
What you need to know before you take Anafranil
3
How to take Anafranil
4
Possible side effects
5
How to store Anafranil
6
Contents of the pack and other information
1. WHAT ANAFRANIL IS AND WHAT IT IS USED FOR
WHAT ANAFRANIL IS
Anafranil
is
available
as
tablets
and
sustained-release
tablets.
The
active
substance
in
Anafranil is clomipramine hydrochloride, which belongs to group of
medicines called tricyclic
antidepressants.
WHAT ANAFRANIL IS USED FOR
Anafranil is used to treat depression and mood disorders. Other
psychological conditions that
can be treated with Anafranil are obsessions, panic states and phobias
(irrational fears),
chronic painful conditions and muscular weakness (cataplexy)
associated with repeat attacks
of extreme sleepiness (narcolepsy) in adults. In children aged above 5
years, Anafranil is used
to treat obsessions and bed-wetting.
HOW ANAFRANIL WORKS
Anafranil is believed to work either by increasing the amount of
naturally occurring chemical
messengers (noradrenaline and serotonin) in the brain or by making
their effects last longer.
If you have any questions about how Anafranil works or why this
medicine has been
prescribed for you, ask your doctor.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANAFRANIL
It is important to tell your doct

Summary of Product characteristics

ANAFRANIL
®
(CLOMIPRAMINE)
10MG, 25MG COATED TABLETS
75MG SUSTAINED-RELEASE TABLET
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ANAFRANIL® 10mg, 25mg coated tablets; 75 mg sustained-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
The
active
ingredient
is
3-Chloro-5-[3-(dimethylamino)-propyl]10,11-dihydro-5H-dibenz-
[b,f]azepine hydrochloride (clomipramine hydrochloride).
One coated tablet contains 10 mg or 25 mg clomipramine hydrochloride.
One
sustained-release
tablet
(divisible
and
non-divisible)
contains
75
mg
clomipramine
hydrochloride.
ACTIVE MOIETY
Clomipramine
EXCIPIENTS
For the full list of excipients, please see section 6.1
3.
PHARMACEUTICAL FORM
Coated tablets (Anafranil® 10, Anafranil 25)
Sustained-release tablets, divisible (Anafranil SR 75 Divitabs)
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULTS
Treatment of depressive states of varying aetiology and
symptomatology, e.g.
• endogenous, reactive, neurotic, organic, masked, and involutional
forms of depression,
• depression associated with schizophrenia and personality
disorders,
• depressive syndromes due to presenility or senility, to chronic
painful conditions, and to
chronic somatic diseases, depressive mood disorders of a reactive,
neurotic, or psychopathic
nature.
Obsessive-compulsive syndromes.
3
Phobias and panic attacks.
Cataplexy accompanying narcolepsy.
Chronic painful conditions.
CHILDREN AND ADOLESCENTS
Nocturnal enuresis (only in patients over the age of 5 years and if
organic causes have been
excluded).
No experience is available in children younger than 5 years of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Before initiating treatment with Anafranil, hypokalaemia should be
treated (see section 4.4
Special warnings and precautions for use). The dosage should be
adapted to the individual
patient's condition. The aim is to achieve an optimum effect while
keeping the doses as low as
possible and increasing them cautiously.
After a response has been obtained, mainten